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The Smith & Nephew MICRORAPTOR Suture Anchor is intended for the reattachment of soft tissue to the following indications:

Hip
Acetabular labrum repair/reconstruction

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis

The Smith & Nephew MICRORAPTOR Suture Anchor consists of an anchor on a flexible and/or straight inserter, flexible and/or straight drill, and curved and/or straight insertion accessory instruments. The implant will be offered in an absorbable material (REGENESORB), single loaded #1 ULTRABRAID suture with multiple suture color offerings. This device is provided sterile, for single use only.

This document is a 510(k) Pre-Market Notification for a medical device called the "MICRORAPTOR REGENESORB Suture Anchor". It describes the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness studies for an AI device is not applicable to this document.

This document describes the following for the MICRORAPTOR REGENESORB Suture Anchor:

1. Acceptance Criteria and Reported Device Performance (Summary):

The performance of the MICRORAPTOR REGENESORB Suture Anchor was evaluated against performance specifications derived from its predicate devices.

Study Description (Summary per the provided text):

The submission refers to "Performance data" to demonstrate that the MICRORAPTOR REGENESORB Suture Anchor met the specified criteria. These appear to be benchtop or laboratory tests, not clinical studies involving human subjects or AI algorithms.

• Bacterial Endotoxin Testing: Was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011.
• Insertion Strength Testing: Performance data demonstrates the device met specifications based on the predicate Pivot NANOTACK Suture Anchor, 1.4mm (K131769).
• Cyclic Loading Testing: Performance data demonstrates the device met specifications based on the predicate OSTEORAPTOR Suture Anchor (K082215).

Given that this document describes a traditional medical device (suture anchor) and not an AI/ML powered device, the following points are not applicable and are therefore marked as "N/A":

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (This is for an AI/ML powered device, not a suture anchor)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (The "ground truth" here is the performance of specified predicate devices and standard endotoxin limits for a physical device)
8. The sample size for the training set: N/A
9. How the ground truth for the training set was established: N/A

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